Red Mountain Compounding Pharmacy Recalls S-Dexpantenol Injection Vials
Red Mountain Compounding Pharmacy is recalling S-Dexpantenol injection vials due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility in an injectable drug corresponds to a Severe severity score.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Dexpantenol 250mg/ml multi-dose vial injection solution. The recall involves 37 30ml glass vials distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. The affected lots include S03072019DH@08, S02142019DH@08, S03072019DH@07, 03072019DH@08, S03042019DH@07, S04172019DT@02, S05232019DT@10, S06242019DH@10, S07172019DT@07, and S07242019DH@09.
Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled items, they should contact their healthcare provider or the pharmacy for instructions on disposal or replacement.
The recalled product
- Product
- S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX
- Category
- Drug — Injectable Solution
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot #: S03072019DH@08
- Exp 9/7/19
- S02142019DH@08
- Exp 8/14/19
- S03072019DH@07
- 03072019DH@08
- 9/7/19
- S03042019DH@07
- Exp 9/4/19
- S04172019DT@02
- Exp 10/17/19
- S05232019DT@10
- Exp 11/23/19
- S06242019DH@10
- Exp 12/24/19
- S07172019DT@07
- Exp 1/17/20
- S07242019DH@09
- Exp 1/24/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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